Methoxypolyethylene glycol-epoetin beta for the treatment of anemia associated with chronic kidney disease.

Therapy with erythropoiesis-stimulating agents (ESAs) is a well-established treatment for renal anemia. ESAs are highly effective at correcting the underlying anemia, restoring energy levels and increasing patient well-being and quality of life. Anemia correction has considerable secondary benefits in terms of morbidity and mortality reduction. However, because of the relatively short halflife of ESAs, they generally have to be administered one to three times weekly in most patients. In order to overcome this shortcoming, in recent years pharmacological research has tried to modify the molecular structure of recombinant human erythropoietin (rHuEpo) in order to improve pharmacokinetics and pharmacodynamics and to allow a reduction in the frequency of administration. Covalent addition of the water-soluble polyethylene glycol moiety has been successfully used to improve the pharmacokinetics of a number of proteins and reduce their immunogenicity. A modified version of rHuEPO incorporating this large polymer chain, called continuous erythropoiesis receptor activator (CERA), has been recently synthesized. Data from animal studies indicate that CERA has a prolonged half-life in comparison with rHuEPO that may allow less frequent administration. Results of phase II and III clinical trials suggest that this agent is effective in maintaining hemoglobin levels after switching from rHuEPO therapy or darbepoetin alpha when administered up to once a month. This less frequent administration schedule may be an advantage for patients and healthcare providers. In addition, this agent may give increased hemoglobin stability over time. Copyright 2008 Prous Science, S.A.U. or its licensors. All rights reserved.